Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2026-01-02 @ 2:39 PM
Study NCT ID:
NCT05718661
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Sponsor:
Trakya University
Organization:
Study Overview
Official Title:
The Effect of Virtual Reality on Preoperative Anxiety Before Abdominal Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hospitalization, medical interventions to be performed, and uncertainties specific to surgical intervention create a certain level of anxiety in the patient. It is known that being in the hospital negatively affects the coping mechanisms of the patient. In the pre-surgical period, the nurse's practices that will facilitate the patient's coping with the situation and managing his anxiety have a positive effect on anxiety during and after surgery and on anxiety-related symptoms. For these reasons, it is aimed to determine the effect of virtual reality on pre-surgical anxiety in this study.The hypothesis of the study is that watching videos with virtual glasses will reduce preoperative anxiety.
Detailed Description:
Questions to be Answered in the Study The questions expected to be answered in the study to be conducted to evaluate the effect of acupressure application on the anxiety level in the preoperative period in patients who will undergo abdominal surgery;
* What is the frequency of anxiety before abdominal surgery?
* What is the effect of virtual reality on anxiety management before abdominal surgery?
Variables of the Research Preoperative anxiety scale/level
Data Collection Tools Patient Information Form, VAS-A and a smart wristband with stress level measurement feature will be used to collect data.
Form-1.Patient Information Form: It is a form consisting of sociodemographic questions created by the researchers.
Form-2. Visual Anxiety Scale (VAS-A): The Numerical Anxiety Severity Scale consists of a horizontal line that begins with the expression "0" or "no anxiety" and ends with the expression "100" or "severe anxiety". The patient is asked to choose the number that best describes the pain, between 0 and 100, by showing the scale. The result of the scale was evaluated over the arithmetic mean (Carr et al 2005; Kindler et al 2000).
Smart Wristband: A smart wristband with photoplethysmography (PPG) feature that detects and reports stress-related changes will be used.
After assessing whether the data fit the normal distribution with the Kolmogorov Smirnov test, if the data fit the normal distribution, parametric tests (Single Sample t-Test, One- and Multi-Way Analysis of Variance, Spearman's Correlation Analysis); if the data do not fit the normal distribution, non-parametric tests (Mann-Whitney U Test, Kruskall Wallis Test, Friedman Test, Pearson's Correlation Analysis) will be used. Mean, standard deviation and percentage distribution methods will be used in the descriptive analysis of the data. The power of the sample will be calculated with the post hoc analysis to be made.
The universe of the research; Between 01.03.2023 and 01.12.2023, all patients who will undergo abdominal surgery in the Trakya University Health Research Center General Surgery Clinic will form.
The sample of the research; The sample will consist of individuals who meet the selection criteria and volunteer to participate in the research.
Sample of the Study: Mosso et al. (2009) in the study titled "Virtual reality on mobile phones to reduce anxiety in outpatient surgery" in which the anxiety levels of patients who used virtual reality in the preoperative period were evaluated using VAS-A. Accordingly, the effect size was calculated as d=0.920. In the calculation of the sample size, using the G-Power (G-Power 3.1.9.7, Kiel, Germany) program, effect size d=0.920, margin of error=0.05, power (1-β err probe)=0.95, 32 patients were included in each group. needed was determined. Using this number; For the initiative group; 32 patients For the control group; 32 patients For the placebo group; The total number of patients to be sampled was planned to be 96, 32 patients.
* What is the frequency of anxiety before abdominal surgery?
* What is the effect of virtual reality on anxiety management before abdominal surgery?
Variables of the Research Preoperative anxiety scale/level
Data Collection Tools Patient Information Form, VAS-A and a smart wristband with stress level measurement feature will be used to collect data.
Form-1.Patient Information Form: It is a form consisting of sociodemographic questions created by the researchers.
Form-2. Visual Anxiety Scale (VAS-A): The Numerical Anxiety Severity Scale consists of a horizontal line that begins with the expression "0" or "no anxiety" and ends with the expression "100" or "severe anxiety". The patient is asked to choose the number that best describes the pain, between 0 and 100, by showing the scale. The result of the scale was evaluated over the arithmetic mean (Carr et al 2005; Kindler et al 2000).
Smart Wristband: A smart wristband with photoplethysmography (PPG) feature that detects and reports stress-related changes will be used.
After assessing whether the data fit the normal distribution with the Kolmogorov Smirnov test, if the data fit the normal distribution, parametric tests (Single Sample t-Test, One- and Multi-Way Analysis of Variance, Spearman's Correlation Analysis); if the data do not fit the normal distribution, non-parametric tests (Mann-Whitney U Test, Kruskall Wallis Test, Friedman Test, Pearson's Correlation Analysis) will be used. Mean, standard deviation and percentage distribution methods will be used in the descriptive analysis of the data. The power of the sample will be calculated with the post hoc analysis to be made.
The universe of the research; Between 01.03.2023 and 01.12.2023, all patients who will undergo abdominal surgery in the Trakya University Health Research Center General Surgery Clinic will form.
The sample of the research; The sample will consist of individuals who meet the selection criteria and volunteer to participate in the research.
Sample of the Study: Mosso et al. (2009) in the study titled "Virtual reality on mobile phones to reduce anxiety in outpatient surgery" in which the anxiety levels of patients who used virtual reality in the preoperative period were evaluated using VAS-A. Accordingly, the effect size was calculated as d=0.920. In the calculation of the sample size, using the G-Power (G-Power 3.1.9.7, Kiel, Germany) program, effect size d=0.920, margin of error=0.05, power (1-β err probe)=0.95, 32 patients were included in each group. needed was determined. Using this number; For the initiative group; 32 patients For the control group; 32 patients For the placebo group; The total number of patients to be sampled was planned to be 96, 32 patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: